SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES


Device Classification Name

panels, test, susceptibility, antimicrobial

510(k) Number K024357
Device Name SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Original Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 keynote circle suite 6
cleveland, 
OH 
44131

Original Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
LTT  
Date Received 12/30/2002
Decision Date 03/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No